DeliriumEarly Phase 1ICUDeliriumNCT00714194
Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients
A Early Phase 1 study testing Normal continuous sedation and Daily interruption of continuous sedation in people with Delirium and Sleep Perception, run by University of California, San Francisco at 1 site in Puerto Rico.
Trial summary
This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Delirium, Sleep Perception
- What is being tested?
- Normal continuous sedation and Daily interruption of continuous sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jul 2008to Sep 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 21 years will be recruited from a Trauma Intensive Care Unit of Puerto Rico. This unit receives critically ill patients with three or more affected body systems involved after motor vehicle accident, gunshot injury, penetrating injury, and falls.
Who cannot join
- Baseline neurological diseases
- Head trauma or acute neurological injury with Glasgow Coma Scale score < 8
- Death expected within 24 hours (APACHE II ≥ 30)
- History of alcoholism
- History of drug dependence
- Deaf and blind patients
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Trauma Unit University of Puerto Rico Medical Center
San Juan
About this study
Official title: The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients
This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU) receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the study. A patient will be entered into the study after the family member has consented to have the patient participate.
Read the detailed description
This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU) receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the study. A patient will be entered into the study after the family member has consented to have the patient participate. A sequential assignment method will be used to compare two groups of 20 patients in each group. The first group of 20 patients (control group [CG]) to be studied will receive continuous sedative infusion without daily interruption. The second group of 20 patients (intervention group [IG]) will receive a daily interruption of sedative infusion.
If control and intervention group data are not sufficient to elicit the effect of daily interruption of sedatives, data collection will continue using the sequential assignment method alternating control and intervention group 10 patients at a time. This method will proceed until an effect is detected or until the a priori sample size of 182 (i.e., 91 patients per group) has been reached.
The intervention group will be monitored during the daily interruption of sedative infusion (i.e., sedation wake-up trial[SWT])in order to measure the following variables: delirium, physiological response (heart rate [HR], respiratory rate [RR], blood pressure [BP], and pulse oxygen saturation [SpO2]), pain intensity, and agitation/sedation level.Once the patient is awake during the SWT period, the patient will be screened for SBT. If the patient meets the SBT criteria, then the mechanical ventilator mode will be changed to continuous positive airway pressure (CPAP) or the patient will be placed in a T-tube circuit for 2 hours or until the patient presents signs of SBT failure. Delirium will be measured 3 times a day for a maximum of 3 days in both groups after continuous deep sedation discontinuation using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Sleep perception will be measured by a sleep questionnaire (Sleep Perception in the ICU) after discontinuous of continuous sedation. Agitation/sedation level will be measured with the Richmond Agitation-Sedation Scale (RASS) and Bispectral Index (BIS), and pain intensity with a 0 to 10 numeric rating scale (NRS).
- Conditions
- Delirium, Sleep Perception
- Being tested
- Normal continuous sedation, Daily interruption of continuous sedation
- Keywords
- sedation, delirium, sleep, sedation withdrawal, ICU patients
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal continuous sedationProcedure or surgery
Normal continuous sedation.
Daily interruption of continuous sedationOther
Also called Ativan®, Versed®, Driprivan®
Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients in the control group will receive continuous sedative infusions without daily interruption of sedatives based on the standard clinical practice of the TICU. Receives: Procedure: Normal continuous sedation |
| 2 | Experimental | Patients in the intervention group will receive daily interruption of sedative. Receives: Other: Daily interruption of continuous sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium and sleep
Measured: 3 days in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geraldine V Padilla, PhD, Study chair, The Regents of the University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714194
- Sponsor's protocol ID
- H41297-32404-01
- Acronym
- ICUDelirium
- Status last verified
- May 2015
- First submitted
- 16 Jun 2008
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients
- ClinicalTrials.gov ID
- NCT00714194
- Acronym / sponsor ID
- ICUDelirium / H41297-32404-01
- Conditions
- Delirium, Sleep Perception
- Keywords
- sedation, delirium, sleep, sedation withdrawal, ICU patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU) receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the study. A patient will be entered into the study after the family member has consented to have the patient participate.
Detailed description
This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU) receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the study. A patient will be entered into the study after the family member has consented to have the patient participate. A sequential assignment method will be used to compare two groups of 20 patients in each group. The first group of 20 patients (control group [CG]) to be studied will receive continuous sedative infusion without daily interruption. The second group of 20 patients (intervention group [IG]) will receive a daily interruption of sedative infusion.
If control and intervention group data are not sufficient to elicit the effect of daily interruption of sedatives, data collection will continue using the sequential assignment method alternating control and intervention group 10 patients at a time. This method will proceed until an effect is detected or until the a priori sample size of 182 (i.e., 91 patients per group) has been reached.
The intervention group will be monitored during the daily interruption of sedative infusion (i.e., sedation wake-up trial[SWT])in order to measure the following variables: delirium, physiological response (heart rate [HR], respiratory rate [RR], blood pressure [BP], and pulse oxygen saturation [SpO2]), pain intensity, and agitation/sedation level.Once the patient is awake during the SWT period, the patient will be screened for SBT. If the patient meets the SBT criteria, then the mechanical ventilator mode will be changed to continuous positive airway pressure (CPAP) or the patient will be placed in a T-tube circuit for 2 hours or until the patient presents signs of SBT failure. Delirium will be measured 3 times a day for a maximum of 3 days in both groups after continuous deep sedation discontinuation using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Sleep perception will be measured by a sleep questionnaire (Sleep Perception in the ICU) after discontinuous of continuous sedation. Agitation/sedation level will be measured with the Richmond Agitation-Sedation Scale (RASS) and Bispectral Index (BIS), and pain intensity with a 0 to 10 numeric rating scale (NRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Normal continuous sedationPatients in the control group will receive continuous sedative infusions without daily interruption of sedatives based on the standard clinical practice of the TICU. |
| 2 | Experimental | Other: Daily interruption of continuous sedationPatients in the intervention group will receive daily interruption of sedative. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 21 years will be recruited from a Trauma Intensive Care Unit of Puerto Rico. This unit receives critically ill patients with three or more affected body systems involved after motor vehicle accident, gunshot injury, penetrating injury, and falls.
Key exclusion criteria (6 listed)
- Baseline neurological diseases
- Head trauma or acute neurological injury with Glasgow Coma Scale score < 8
- Death expected within 24 hours (APACHE II ≥ 30)
- History of alcoholism
- History of drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal continuous sedationNormal continuous sedation. | Procedure or surgery | 1 |
| Daily interruption of continuous sedationAlso: Ativan®, Versed®, Driprivan®Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation. | Other | 2 |
Primary outcome
Delirium and sleep
Time frame: 3 days in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine V Padilla, PhD study chair
The Regents of the University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Normal continuous sedation and Daily interruption of continuous sedation in people with Delirium and Sleep Perception, run by University of California, San Francisco at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium and sleep (time frame: 3 days in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.